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Ampicillin 2 g Injection, Powder, For Solution, 10 vials — NDC 83270-0314-10 package photo

Ampicillin 2 g Injection, Powder, For Solution, 10 vials

by ONESOURCE SPECIALTY PHARMA LIMITED · 10 VIAL in 1 CARTON (83270-314-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
NDC 83270-0314-10
🏷️ FDA NDC (as labeled) 83270-314-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 83270-314-10
Product NDC 83270-314
11-digit billing NDC 83270031410
UNII JFN36L5S8K
UPC 0383270313019
Application # ANDA201025
SPL Set ID 519f2131-79e7-569f-e063-6394a90a2f93
Established class (EPC) Penicillin-class Antibacterial
Chemical class Penicillins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-27
Route INTRAVENOUS
Dosage form INJECTION, POWDER, FOR SOLUTION
Substance AMPICILLIN SODIUM
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 83270-314-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 83270-0314-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Penicillin-class Antibacterial class.

Pharmacologic class Penicillin-class Antibacterial
Drug family (ATC) Penicillins with extended spectrum, Antibiotics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerONESOURCE SPECIALTY PHARMA LIMITED
Application holderONESOURCE SPECIALTY PTE LTD
FDA applicationANDA201025 (ANDA)
Labeler code83270
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio53 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Ampicillin treats a range of bacterial infections — things like respiratory infections, urinary tract infections, stomach and intestinal infections including typhoid fever, and mor...
  • What kinds of infections does ampicillin treat?
  • Follow the instructions your prescriber or pharmacist gave you specifically for your prescription. If you're unsure, check with your pharmacist — they can confirm whether your part...
  • Is it okay to take the capsules with food?
📖 Read our full Ampicillin guide →
7
Nutrient depletion considerations

Ampicillin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $3.51
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ampicillin 2 g 00404-9818-99 Henry 1 vial AP FDA listed
Ampicillin 2 g 00781-3408-95 Sandoz 10 vials AP FDA listed
Ampicillin 2 g 00781-3413-92 Sandoz 10 vials FDA listed
Ampicillin 2 g 00781-9273-95 Sandoz 10 vials AP FDA listed
Ampicillin 2 g 00781-9408-95 Sandoz 10 vials AP FDA listed
Ampicillin 2 g 00781-9413-92 Sandoz 10 vials FDA listed
Ampicillin 2 g/2g 23155-0917-41 Heritage 10 vials AP FDA listed
ampicillin 2 g 25021-0137-20 Sagent 10 vials AP FDA listed
Ampicillin 2 g 44567-0103-10 WG 10 vials AP FDA listed
Ampicillin 2 g 51662-1560-03 HF 10 pouches AP FDA listed
Ampicillin 2 g 55150-0114-20 Eugia 10 vials AP FDA listed
Ampicillin 2 g 65219-0020-23 Fresenius 10 vials AP FDA listed
Ampicillin 2 g 71872-7139-01 Medical 1 vial AP FDA listed
Ampicillin 2 g 71872-7240-01 Medical 1 vial AP FDA listed
Ampicillin sodium 2 g 71872-7342-01 Medical 1 vial AP FDA listed
Ampicillin sodium 2 g 72485-0422-10 Armas 10 vials AP FDA listed
Ampicillin 2 g 72572-0017-10 Civica, 10 vials AP FDA listed
Ampicillin sodium 2 g 72572-0094-10 Civica, 10 vials AP FDA listed
Ampicillin 2 g 72603-0454-10 NorthStar 10 vials AP FDA listed
Ampicillin 2 gthis 83270-0314-10 ONESOURCE 10 vials AP FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83270-0314-10 You're viewing this 10 VIAL in 1 CARTON (83270-314-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 2026-02-27 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 83270-314-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 83270-0314-10, written without dashes as 83270031410. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 83270-0314-10, the first segment (83270) is the labeler code FDA assigned to ONESOURCE SPECIALTY PHARMA LIMITED; the middle segment (0314) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ONESOURCE SPECIALTY PHARMA LIMITED. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ONESOURCE SPECIALTY PHARMA LIMITED is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~1 min read

INDICATIONS AND USAGE Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory tract Infections caused by Streptococcus pneumoniae . Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae , and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli , Group B Streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis ).

The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp ., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin.

Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis .

Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed.

Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Indicated surgical procedures should be performed.

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION Infections of the respiratory tract and soft tissues. Patients weighing 40 kg (88 lbs) or more : 250 to 500 mg every 6 hours. Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females). Patients weighing 40 kg (88 lbs) or more : 500 mg every 6 hours. Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections.

In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Urethritis in males due to N. gonorrhoeae.

Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required. In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended.

Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. The doses for the preceding infections may be given by either the intramuscular or intravenous route.

A change to oral ampicillin may be made when appropriate. Bacterial Meningitis Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

Neonates (less than or equal to 28 days of postnatal age) - Dosage should be based on Gestational age and Postnatal age according to Table 3. TABLE 3: Dosage in Neonates (less than or equal to 28 days of postnatal age) for Bacterial Meningitis and Septicemia: Gestational age (weeks) Postnatal age (days) Dosage less than or equal to 34 less than or equal to 7 100 mg/kg/day in equally divided doses every 12 hours less than or equal to 34 greater than or equal to 8 and less than 28 150 mg/kg/day in equally divided doses every 12 hours greater than 34 less than or equal to 28 150 mg/kg/day in equally divided doses every 8 hours Septicemia Adults and children – 150 to 200 mg/kg/day.

Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours. Neonates (less than or equal to 28 days of postnatal age) - Dosage should be based on Gestational age and Postnatal age according to Table 3 (above). Treatment of all infections should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.

A minimum of 10 days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis. DIRECTIONS FOR USE Use only freshly prepared solutions. Intramuscular and intravenous injections should be administered within one hour after preparation since the potency may decrease significantly after this period.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For Intramuscular Use – Dissolve contents of a vial with the amount of Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, listed in the table below: Recommended Withdrawable Concentration NDC Lab…

Contraindications 16 words

CONTRAINDICATIONS A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

⚠️ Warnings ~1 min read

WARNINGS Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.

There have been well-documented reports of individuals with a history of penicillin hypersensitivity reactions who have experienced severe hypersensitivity reactions when treated with a cephalosporin. Before initiating therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.

SERIOUS ANAPHYLACTOID REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE, OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ampicillin for Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile .

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of ampicillin: Gastrointestinal Glossitis, stomatitis, black “hairy” tongue, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea.

(These reactions are usually associated with oral dosage forms.) Hypersensitivity Reactions Skin rashes and urticaria have been reported frequently. A few cases of exfoliative dermatitis and erythema multiforme have been reported. Linear IgA bullous dermatosis has been reported.

Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form. Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, ampicillin should be discontinued, unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to ampicillin therapy.

Serious anaphylactic reactions require the immediate use of epinephrine, oxygen, and intravenous steroids. Liver – A moderate rise in serum glutamic oxaloacetic transaminase (SGOT) has been noted, particularly in infants, but the significance of this finding is unknown. Mild transitory SGOT elevations have been observed in individuals receiving larger (two to four times) than usual and oft-repeated intramuscular injections.

Evidence indicates that glutamic oxaloacetic transaminase (GOT) is released at the site of intramuscular injection of ampicillin sodium and that the presence of increased amounts of this enzyme in the blood does not necessarily indicate liver involvement. Hemic and Lymphatic Systems – Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Central Nervous System - Seizures To report SUSPECTED ADVERSE REACTIONS, contact Onesource at 1-888-217-8103 or www.onesourcecdmo.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧒 Pediatric Use 20 words

Pediatric Use Guidelines for the administration of these drugs to children, including neonates are presented in DOSAGE AND ADMINISTRATION section.

🆘 Overdosage 32 words

OVERDOSAGE In cases of overdose, discontinue medication, treat symptomatically, and institute supportive measures as required. In patients with renal function impairment, ampicillin-class antibiotics can be removed by hemodialysis but not peritoneal dialysis.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Ampicillin for Injection diffuses readily into most body tissues and fluids. However, penetration into the cerebrospinal fluid and brain occurs only when the meninges are inflamed. Ampicillin is excreted largely unchanged in the urine and its excretion can be delayed by concurrent administration of probenecid.

Due to maturational changes in renal function, ampicillin half-life decreases as postmenstrual age (a sum of gestational age and postnatal age) increases for infants with postnatal age of less than 28 days. The active form appears in the bile in higher concentrations than those found in serum. Ampicillin is the least serum-bound of all the penicillins, averaging about 20% compared to approximately 60 to 90% for other penicillins.

Ampicillin for Injection is well tolerated by most patients and has been given in doses of 2 grams daily for many weeks without adverse reactions. Microbiology While in vitro studies have demonstrated the susceptibility of most strains of the following organisms, clinical efficacy for infections other than those included in the INDICATIONS AND USAGE section has not been demonstrated. Antibacterial Activity The following bacteria have been shown in in vitro studies to be susceptible to Ampicillin for Injection, USP: Gram-positive Bacteria Hemolytic and nonhemolytic streptococci Streptococcus pneumoniae Nonpenicillinase-producing staphylococci Clostridium spp.

B. anthracis Listeria monocytogenes Most strains of enterococci. Gram-negative Bacteria H. influenzae N. gonorrhoeae N. meningitis Proteus mirabilis Many strains of Salmonella , Shigella , and E. coli . AMPICILLIN does not resist destruction by penicillinase.

Susceptibility Testing For specifc information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see:https://www.fda.gov/STIC.

📦 How Supplied / Storage and Handling 132 words

HOW SUPPLIED Ampicillin for Injection, USP for IM or IV Injection. Each vial of Ampicillin for Injection contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram, or 2 grams ampicillin. NDC 83270-311-10 250 mg vial packaged in 10s NDC 83270-312-10 500 mg vial packaged in 10s NDC 83270-313-10 1 gram vial packaged in 10s NDC 83270-314-10 2 grams vial packaged in 10s STORAGE AND HANDLING Store dry powder at 20 o to 25 o C (68 o to 77 o F). [See USP controlled room temperature.] Protect the constituted solution from freezing.

Clinitest is a registered trademark of Miles, Inc. Clinistix is a registered trademark of Bayer Corporation. Tes-Tape is a registered trademark of Eli Lilly Company.

Manufactured by: OneSource Specialty Pharma Limited Beta Lactam Division, Bengaluru-560076, India. February 2026

📦 Storage and Handling 68 words

STORAGE AND HANDLING Store dry powder at 20 o to 25 o C (68 o to 77 o F). [See USP controlled room temperature.] Protect the constituted solution from freezing. Clinitest is a registered trademark of Miles, Inc. Clinistix is a registered trademark of Bayer Corporation. Tes-Tape is a registered trademark of Eli Lilly Company. Manufactured by: OneSource Specialty Pharma Limited Beta Lactam Division, Bengaluru-560076, India. February 2026

📋 Description 162 words

DESCRIPTION Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a white to off-white crystalline sterile powder and forms a clear colorless solution upon reconstitution with sterile water for injection, USP or Bacteriostatic water for injection, USP.

Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 gram ampicillin. The sodium content is 16.46 mg (0.71 mEq) per 250 mg, 32.91 mg (1.43 mEq) per 500 mg, 65.83 mg (2.86 mEq) per 1 g, 131.66 mg (5.72 mEq) per 2 g of ampicillin. It has the following molecular structure: The molecular formula is C 16 H 18 N 3 NaO 4 S, and the molecular weight is 371.39.

The pH range of the reconstituted solution is 8 to 10. structure

💬 Information for Patients ~2 min read

Information for Patients Patients should be counseled that antibacterial drugs including ampicillin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ampicillin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ampicillin or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible. Laboratory Tests As with any potent drug, periodic assessment of organ system function, including renal, hepatic, and hematopoietic, should be made during prolonged therapy. Transient elevation of serum transaminase has been observed following administration of ampicillin.

The significance of this finding is not known. Drug Interactions The concurrent administration of allopurinol and ampicillin increases substantially the incidence of skin rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

Drug/Laboratory Test Interactions With high urine concentrations of ampicillin, false-positive glucose reactions may occur if Clinitest, Benedict's Solution, or Fehling's Solution are used. Therefore, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix or Tes-Tape) be used. Carcinogenesis, Mutagenesis, and Impairment of Fertility No long-term animal studies have been conducted with this drug.

Pregnancy - Category B Reproduction studies have been performed in laboratory animals at doses several times the human dose and have revealed no evidence of adverse effects due to ampicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.